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Is the regulator’s premises consultation pharmacy’s Great Leap Forward?

Right-touch regulation is fine for pharmacists and pharmacy technicians. But there are serious doubts about its applicability it to the regulation of pharmacy premises

By Joy Wingfield and Roger Kirkbride

Joy Wingfield Honorary professor of law and ethics, Nottingham University, Roger Kirkbride Owner and superintendent

Anyone who doubts the significance of separating pharmacy’s regulator from its leadership body should study carefully the proposed General Pharmaceutical Council (GPhC) standards for registered pharmacies. If you think that because you do not own or are the superintendent of a pharmacy, this consultation does not affect you, then you are wrong. Front-line pharmacists are expected to be the eyes and ears of the regulator in raising concerns with their employer about any shortfall in meeting the standards, in particular standard 2.2, which requires the owner or superintendent to ensure professional staff are empowered to exercise their professional judgement in the best interests of patients and the public.

Although the former regulator, the Royal Pharmaceutical Society of Great Britain, did indeed prescribe in detail the minimum facilities, equipment and processes to be expected from a pharmacy (largely in response to persistent demand from its members for it to do so) the GPhC approach more or less describes what a good pharmacy should look like and leaves owners and superintendents to decide how to get there. This reflects the right-touch approach — the minimum regulatory force required to achieve the desired result — espoused by the Council for Healthcare Regulatory Excellence and hence the GPhC.

Trusted

In essence, right-touch regulation of health and social care professionals recognises that the best protection for patients using health and social care services lies in the availability of competent, caring individuals at the point of receipt of care. The regulator then aims to act as a reliable guarantor for the performance and conduct of each of its registrants by setting standards for training, professionalism and continuing competence as well as mechanisms to deal with impaired fitness to practise.

So far, so good; pharmacists and technicians should be trusted in the first place to be professional and to be imbued with the knowledge, skills and judgement to achieve professional outcomes and decisions without a detailed rule book. It is for other pharmacy bodies to provide practical advice and guidance if needed.

This may well be a valid approach for the regulation of healthcare professionals but we have serious reservations about its applicability to pharmacies at the present time. We suggest that focusing on an outcomes-only approach to standards for registered pharmacies has a number of serious flaws, not least the assumption that the professionalism of individual pharmacists will automatically characterise the attitudes and behaviours of those who own or operate pharmacies.
UK pharmacy is like no other UK healthcare profession or any other European country in terms of its ownership structure.

Less than 40 per cent of premises are in the hands of independent pharmacy professionals. This means that the great majority of premises, and pharmacy professionals operating in them, are subject to overtly commercial pressures. The key imperative of corporate retailers is to deliver shareholder returns equal to or better than those expected. Operating costs and market share are the major considerations.  Patient care is merely an intermediate measure; only factors which may impact on patient numbers (waiting times, prescription collection and delivery) are considered important.

Furthermore, over a third of UK pharmacies are owned by companies based outside the UK, and their commitment to the NHS and UK patients extends only as far as their profitability. A further 14 per cent of pharmacies are owned by general retailing groups; their motivation — aside from the profitability of the operation — is to drive footfall. The value of each visitor is much greater as a customer of the general retailing part of the store than their value as a user of the pharmacy.

Corporate chains are not owned or run by pharmacists; often the managers of pharmacists working in those stores are not themselves pharmacists. Moreover, the power and influence of the superintendent pharmacist is frequently constrained by not being on or recognised by the main board and conflicted by his or her obligation as an employee to contribute to the commercial goals of the company — or lose the job.

The GPhC cannot change the ownership structure of UK pharmacy but it should take more notice of the 2009 judgment in the European Court of Justice (case C-531/06 and joined cases C-171/07 and C-182/07) which affirmed the right of member states to determine how they regulate pharmacy to ensure the professional independence of the pharmacist. It will take rather more than writing a clause or two “in an employment contract”, as suggested by compliance indicator for standard 2.2, to protect a pharmacist who claims professional judgement as a reason to infringe a standard operating procedure or for failing to meet that month’s service targets.

The setting of aspirational standards for outcomes is worthy but every player in the team can be compromised: the owner by commercial imperatives to make a profit; the superintendent in a large corporation by lack of real power; and the employee and locum who are supposed to whistleblow on any shortcomings by rapidly losing employment choices if they do so.

More time

Little guidance or resource to achieve the expected outcomes is currently available to help pharmacists who wish to become new owners or superintendents. It may not be the job of the GPhC to develop this material but it should recognise that outcomes are the endpoint of an activity; their expression should incentivise significant development of training in how to run a successful pharmacy commercially and professionally, for example, covering risk management, safeguarding processes and handling complaints. However, this will take considerably more time than is suggested in the GPhC consultation.

More time will also be needed to establish a credible assessment framework and train GPhC inspectors to apply it. The compliance indicators currently suggested are helpful but we can think of more searching questions (see Panel). The consultation states that the GPhC intends to “move away” from the current inspection model which manages visits only every three years. A move in which direction? Is the proposed reduction in GPhC fees (also under consultation) indicative of even less frequent checks in the future? Although inspectors’ visits may not be the most welcome of events they are a valuable mechanism for articulating concerns about one’s own or other pharmacies.

Some searching questions

Standards will require flexibility and judgement on behalf of the assessor/ inspector because compliance will vary according to prevailing circumstances, such as prescription volume or services undertaken

• How is the professional independence of employee and locum pharmacy professionals assured and demonstrated?
• Does prescription volume inhibit the pharmacist’s ability to concentrate sufficient time on the patient?
• Are there sufficient support staff? Do they have the right skills, competence and experience?
• Are processes enhancing or stifling the opportunity to engage with patients?
• Do systems help or hinder? (For example, systems that flag up every possible drug interaction, however unlikely or trivial, result in such warnings being ignored. Too many or too detailed standard operating procedures may constrain professional flexibility and judgement.)
• Are local managers providing a supportive environment or are they making life difficult for pharmacists?
• Are targets, incentives and performance measures applying inappropriate pressure on professional practice?

 

The consultation also states that it will publish “risk indicators” when the new standards come into force and that these will be based on feedback from pharmacy staff, employers, patients and the public as well as data on the services you offer. Although the theory may be sound, we struggle to see how objective indicators can be developed before the end of the year, as implied in the consultation.

The most graphic illustration of the GPhC approach relates to the question of restricting self-selection of pharmacy medicines. It proposes that this will be for the owner or superintendent to decide based on a “demonstration” that, as suggested in the compliance indicator for standard 4, they have given this matter some “consideration”. Well, that is all right then. If the goals of the pharmacy owner were congruent with the goals of individual pharmacists this might just be a tenable option — but mostly they are not. If through this “consideration” by the owner pharmacy medicines are put on open shelves and not treated as being anything special, then is the Medicines and Healthcare products Regulatory Agency ever likely to sanction a prescription-only to pharmacy medicine change again?

It is laudable that the GPhC wants to treat the pharmacy profession as “grown ups” who do not need detailed checklists to tell them how to behave. For registered pharmacies, however, it is far too big a step (akin to jumping from A to Z without bothering with the rest of the alphabet) to take without proper regard for the commercial environment, the culture and habits of current pharmacists and the lack of resource to make this transition in one leap.

Great Leaps Forward tend to result in casualties; we urge that much more attention is paid to the context of pharmacy operations before these proposals come anywhere near the attributes of right-touch regulation.

 

Citation: The Pharmaceutical Journal URI: 11099586

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